Simplify 5709424P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00195377105455), received between Nov 20, 2023 and Jun 23, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Implant subsidence” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P200022); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Implant subsidence

  IT WAS REPORTED THAT THE ORIGINAL SIMPLIFY DISC IMPLANT SURGERY WAS DONE ON (B)(6) 2026. ON (B)(6) 2026 THE SURGEON EXPLANTED THE SIMPLIFY DISC DUE TO KYPHOSIS AND SUBSIDENCE AND PERFORMED AN ANTERIOR CERVICAL DISCECTOMY AND FUSION.

  Patient problems: Insufficient Information

  MAUDE report 25598199 ↗
• MalfunctionMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SIMPLIFY DISC WAS EXPLANTED DUE TO PAIN AND OSTEOLYSIS SEEN ON CT SCAN. EXPLANT DATE (B)(6) 2026.

  Patient problems: Osteolysis

  MAUDE report 24651539 ↗
• MalfunctionAug 26, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT A SIMPLIFY IMPLANT WAS CHIPPED WHILE BEING REVISED INTRAOPERATIVELY, IT WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898592 ↗
• MalfunctionMar 18, 2025Implant subsidence; Implant subsidence

  ON AN UNKNOWN DATE A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR). DURING THE 3 MONTH FOLLOW UP THE SURGEON NOTED POST OPERATIVE SUBSIDENCE AT THE INDEX LEVEL. NO REVISION IS PLANNED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638886 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 A PATIENT UNDERWENT A CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C5/6. ON (B)(6) 2025 IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL AFTER WHICH THE SURGEON NOTICED LUCENCY AROUND THE SIMPLIFY END PLATES POSTERIORLY AND SLIGHT CERVICAL KYPHOSIS IN AN MRI AND A REVISION WAS PERFORMED. THE CTDR AT C5/6 WAS REMOVED AND REPLACED WITH AN INTEGRATED INTERBODY CAGE FUSION. NO ADDITIONAL PROBLEMS NOTED.

  Patient problems: Fall; Head Injury; Neck Pain

  MAUDE report 21283248 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A PATIENT UNDERWENT A TWO-LEVEL CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C4/5 AND C5/6 TO TREAT MILD STENOSIS. ON (B)(6) 2024, A REVISION TOOK PLACE DUE TO SIGNS OF OSTEOLYSIS BOTH DISCS REMOVED. C4/5.

  Patient problems: Osteolysis

  MAUDE report 20880975 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 A PATIENT UNDERWENT A TWO-LEVEL CERVICAL TOTAL DISC REPLACEMENT (CTDR) AT C4/5 AND C5/6 TO TREAT MILD STENOSIS. ON (B)(6) 2024 A REVISION TOOK PLACE DUE TO SIGNS OF OSTEOLYSIS. C5/6

  Patient problems: Osteolysis

  MAUDE report 20880748 ↗
• InjuryNov 20, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE (1) LEVEL TOTAL DISC REPLACEMENT AT C6/7. SUBSEQUENTLY, APPROXIMATELY TWO (2) WEEKS LATER, THE INFERIOR ENDPLATE OF THE DISC PROSTHESIS HAD SUBSIDED INTO THE CAUDAL VERTEBRAL BODY (C7). NO INFORMATION WAS AVAILABLE REGARDING THE PATIENT'S BONE DENSITY. APPROXIMATELY TWO (2) WEEKS LATER THE PATIENT WAS REVISED TO AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). THE EXPLANTED DEVICE WAS REQUESTED FOR RETURN; HOWEVER, WAS NOT ABLE TO BE RETRIEVED FROM THE FACILITY. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200022. One submission often covers many models, so check the product and lot details in each record.

• Z-1453-2022 · Jun 20, 2022 · Open, Classified
  Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht